scholarly journals Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals

Biologicals ◽  
2021 ◽  
Author(s):  
Elliot Lilley ◽  
Richard Isbrucker ◽  
Ian Ragan ◽  
Anthony Holmes
Keyword(s):  
Who Guidelines ◽  
Batch Release ◽  
Release Testing

scholarly journals Potency Assessment of Dendritic Cell Anticancer Vaccine: Validation of the Co-Flow DC Assay

2021 ◽  
Vol 22 (11) ◽  
pp. 5824
Author(s):  
Silvia Carloni ◽  
Claudia Piccinini ◽  
Elena Pancisi ◽  
Valentina Soldati ◽  
Monica Stefanelli ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Quality Control ◽  
T Cell ◽  
Cell Interaction ◽  
T Cell Proliferation ◽  
Batch Release ◽  
High Level ◽  
Anticancer Vaccine ◽  
True Values ◽  
Release Testing

For many years, oncological clinical trials have taken advantage of dendritic cells (DC) for the design of DC-based cellular therapies. This has required the design of suitable quality control assays to evaluate the potency of these products. The purpose of our work was to develop and validate a novel bioassay that uses flow cytometry as a read-out measurement. In this method, CD3+ cells are labeled with a fluorescent dye and the DC costimulatory activity is measured by the degree of T cell proliferation caused by the DC–T cell interaction. The validation of the method was achieved by the evaluation of essential analytical parameters defined by international guidelines. Our results demonstrated that the method could be considered specific, selective, and robust. The comparison between measured values and estimated true values confirmed a high level of accuracy and a lack of systematic error. Repeated experiments have shown the reproducibility of the assay and the proportionality between the potency and the DC amount has proven its linearity. Our results suggest that the method is compliant with the guidelines and could be adopted as a quality control assay or batch-release testing within GMP facilities.

Drivers and barriers in the consistency approach for vaccine batch release testing: Report of an international workshop

Biologicals ◽  
2017 ◽  
Vol 48 ◽  
pp. 1-5 ◽  
Author(s):  
Martijn W.P. Bruysters ◽  
Marie-Jeanne Schiffelers ◽  
Marieke Hoonakker ◽  
Carmen Jungbaeck ◽  
Ian Ragan ◽  
...  
Keyword(s):  
International Workshop ◽  
Batch Release ◽  
Release Testing

scholarly journals Regulatory issues in pandemic influenza vaccine development

2006 ◽  
Vol 27 (4) ◽  
pp. 172
Author(s):  
Gary Grohmann
Keyword(s):  
Pandemic Influenza ◽  
Adverse Reactions ◽  
Vaccine Development ◽  
Vaccine Safety ◽  
Influenza Vaccines ◽  
Efficacy And Safety ◽  
Batch Release ◽  
Post Market ◽  
Release Testing ◽  
Selection Of

The Therapeutic Goods Administration (TGA) is responsible for the licensing of vaccines used in Australia. This includes pre-market evaluation aspects (such as assessing the quality, efficacy and safety of vaccines) and post-market aspects (such as batch release testing and the monitoring of adverse reactions). For inter-pandemic and pandemic influenza vaccines, TGA is also involved in the selection of appropriate vaccine viruses and the calibration and supply of reagents for the production of influenza vaccines. Together with industry, TGA has a responsibility to ensure that all regulatory and good manufacturing requirements (GMP) are met to ensure vaccine safety and efficacy.

A Machine Learning Application for Raising WASH Awareness in the Times of COVID-19 Pandemic (Preprint)

2020 ◽  
Author(s):  
Rohan Pandey ◽  
Vaibhav Gautam ◽  
Ridam Pal ◽  
Harsh Bandhey ◽  
Lovedeep Singh Dhingra ◽  
...  
Keyword(s):  
Machine Learning ◽  
Natural Language Processing ◽  
Natural Language ◽  
Machine Translation ◽  
Language Processing ◽  
User Feedback ◽  
Who Guidelines ◽  
The Times ◽  
The Right ◽  
Local Languages

BACKGROUND The COVID-19 pandemic has uncovered the potential of digital misinformation in shaping the health of nations. The deluge of unverified information that spreads faster than the epidemic itself is an unprecedented phenomenon that has put millions of lives in danger. Mitigating this ‘Infodemic’ requires strong health messaging systems that are engaging, vernacular, scalable, effective and continuously learn the new patterns of misinformation. OBJECTIVE We created WashKaro, a multi-pronged intervention for mitigating misinformation through conversational AI, machine translation and natural language processing. WashKaro provides the right information matched against WHO guidelines through AI, and delivers it in the right format in local languages. METHODS We theorize (i) an NLP based AI engine that could continuously incorporate user feedback to improve relevance of information, (ii) bite sized audio in the local language to improve penetrance in a country with skewed gender literacy ratios, and (iii) conversational but interactive AI engagement with users towards an increased health awareness in the community. RESULTS A total of 5026 people who downloaded the app during the study window, among those 1545 were active users. Our study shows that 3.4 times more females engaged with the App in Hindi as compared to males, the relevance of AI-filtered news content doubled within 45 days of continuous machine learning, and the prudence of integrated AI chatbot “Satya” increased thus proving the usefulness of an mHealth platform to mitigate health misinformation. CONCLUSIONS We conclude that a multi-pronged machine learning application delivering vernacular bite-sized audios and conversational AI is an effective approach to mitigate health misinformation. CLINICALTRIAL Not Applicable

scholarly journals 2020 WHO guidelines on physical activity and sedentary behavior

2021 ◽  
Author(s):  
Anthony D. Okely ◽  
Anna Kontsevaya ◽  
Johan Ng ◽  
Chalchisa Abdeta
Keyword(s):  
Physical Activity ◽  
Sedentary Behavior ◽  
Who Guidelines

scholarly journals Identifying factors that influenced wellbeing and learning effectiveness during the sudden transition into eLearning due to the COVID-19 lockdown

Work ◽  
2021 ◽  
Vol 68 (1) ◽  
pp. 45-67
Author(s):  
Alessandro Naddeo ◽  
Rosaria Califano ◽  
Iolanda Fiorillo
Keyword(s):  
Coming Out ◽  
Online Courses ◽  
Learning Effectiveness ◽  
Who Guidelines ◽  
Human Comfort ◽  
Factors Influencing ◽  
Rapid Changes ◽  
Sudden Transition ◽  
Teaching Learning ◽  
Educational Delivery

BACKGROUND: The sanitary emergency due to COVID-19 virus obliged people to face up several changes in their everyday life becauseWorld Health Organisation (WHO) guidelines and countries' Health Systems imposed lockdown of activities and social distancing to flatten the infection curve. One of these rapid changes involved students and professors that had to turn the traditional "in presence" classes into online courses facing several problems for educational delivery. OBJECTIVES: This work aimed to investigate the factors that affected both teaching/learning effectiveness and general human comfort and wellbeing after the sudden transition from classrooms to eLearning platforms due to COVID-19 in Italy. METHODS: A workshop, involving students and experts of Human Factors and Ergonomics, has been performed to identify aspects/factors that could influence online learning. Then, from workshop output and literature studies, a survey composed of two questionnaires (one for students and one for teachers) has been developed and spread out among Italian universities students and professors. RESULTS: 700 people answered the questionnaires. Data have been analysed and discussed to define the most important changes due to the new eLearning approach. Absence of interactions with colleagues and the necessity to use several devices were some of the aspects coming out from questionnaires. CONCLUSIONS: The study shows an overview of factors influencing both teaching/learning effectiveness and general human comfort and wellbeing. Results could be considered as a basis for future investigation and optimization about the dependencies and correlations among identified factors and the characteristics of the products/interaction/environment during eLearning courses.

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